RecruitingNot ApplicableNCT06452186

Restoration of Normative Postural Control

Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles


Sponsor

North Carolina State University

Enrollment

50 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this proposal is to investigate the effects of training to use direct electromyographic (dEMG) control of a powered prosthetic ankle on transtibial amputees'. The aimed questions to answer: 1. whether dEMG control will improve balance and postural stability of amputees, 2. whether dEMG control will lead to more natural neuromuscular control and coordination, 3) whether dEMG control will reduce cognitive processes. Participants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks. The results will be compared with a comparison group, which goes through the same training but with their everyday passive prostheses on balance capability, neuromuscular coordination, and cognitive load during locomotion.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria7

  • years or older;
  • unilateral bower limb amputee
  • K-level 2 or higher (who are frequent prosthesis users and may benefit from the proposed prosthesis training and use of dEMG controlled powered prosthesis)
  • Amputation occurred over 2 years ago
  • At least 1 year of experience using their prosthetic leg
  • Has used the current socket for at least 6 months without a significant skin issue or major modification
  • Are willing to come to NC State University's Centennial Campus to participate in research and be photographed while doing research activities

Exclusion Criteria8

  • Have a very short residual shank (the length of the residual limb is ≤15% of the length of intact limb)
  • Cannot perform functional ambulation in the community on a daily basis without assistive devices
  • Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
  • Congenital amputees
  • Amputees who use powered prosthetic ankles
  • Weight more than 300lbs
  • Pregnant Person
  • Allergic to latex, which is often contained in medical tapes.

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Interventions

DEVICEdirect EMG controlled prosthetic ankle

Patients are trained to use the powered prosthetic ankles

BEHAVIORALPT guided prosthetic training

Amputees are trained to use prosthetic ankles


Locations(1)

North Carolina State University

Raleigh, North Carolina, United States

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NCT06452186


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